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A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree)

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ClinicalTrials.gov Identifier: NCT01885221
Recruitment Status : Active, not recruiting
First Posted : June 24, 2013
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Multimedia Support Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation
Study Start Date : September 2012
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multimedia Support Intervention
(a) access to a website providing the content of our supporter guidebook, supplemented with interactive components, video elements, and a supporters' forum, and (b) a mailed copy of our supporter guidebook
Behavioral: Multimedia Support Intervention
No Intervention: Delayed Treatment Control
Access to the Multimedia Intervention after participant completes the final follow-up assessment



Primary Outcome Measures :
  1. smokeless tobacco cessation [ Time Frame: 7.5-month follow-up ]
    the male ST user's 6-month cessation as reported by the female partner


Secondary Outcome Measures :
  1. tobacco quit attempts [ Time Frame: 7.5 month follow-up ]
    the male smokeless tobacco user's quit attempts, as reported by the female partner

  2. supportive behaviors [ Time Frame: 7.5 month follow-up ]
    change in the female partner's supportive behaviors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • being the wife or female domestic partner (living together) of a male who is a current user of ST products (snuff or chewing tobacco)
  • interested in having him quit ST use
  • willing to provide a phone number, mailing address, and e-mail address
  • provides informed consent
  • the woman and the chewer are both U.S. or Canadian residents age 18 or older
  • the woman and the chewer are both able to read English
  • the woman and the chewer are both able to access a computer

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885221


Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Laura E Akers, Ph.D. Oregon Research Institute

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01885221     History of Changes
Other Study ID Numbers: DA033422
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Oregon Research Institute:
smokeless tobacco cessation
social support
partner support

Additional relevant MeSH terms:
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents